Eye stents and delivery systems

ABSTRACT

Some embodiments of the invention advantageously leverage the expansion, dilation or by-pass of the Schlemm&#39;s canal using adjustable reversible self-expanding eye stents (SES) or eye tension rings (ETRs) of desired sizes to control and improve aqueous flow throughout the range of the uveolymphatic canal. As such, some embodiments include tension ring(s) or cylinders that sits either inside or outside the Schlemm&#39;s canal wall and is at least partially within the canal and/or is partially or fully anchored, attached, adhered, or otherwise held in place with respect to the wall and/or elsewhere in the canal. The partial or complete expansion of the canal can be pre-configured based on pre-operative metrology of the Schlemm&#39;s canal to a customized and adjustable fit across the various zones within the uveolymphatic canal and based on the patient specific and evolving needs. Additionally, the SES can utilize entry/exit features for by-pass of fluid, varying control of dilation across its shape that may also allow anchoring, repositioning, and retrieval.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of PCT/US2020/041704(Attorney Docket No. 58141-703.601), filed Jul. 10, 2020, which claimsthe benefit of U.S. Provisional No. 62/872,494 (Attorney Docket No.58141-703.101), filed Jul. 10, 2019; U.S. Provisional No. 62/874,946(Attorney Docket No. 58141-703.102), filed Jul. 16, 2019; and U.S.Provisional No. 62/945,160 (Attorney Docket No. 58141-703.103), filedDec. 8, 2019, the entire contents of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION

Glaucoma is the second leading cause of blindness in the world and everyyear, several millions of Americans lose their sight to this disablingand degenerative disease. Glaucoma is a condition that results from theelevated intraocular pressure due to various factors that irreversiblydamage the eye's optic nerve. Glaucoma tends to be inherited and may nothave any symptoms leading to the signs. It is estimated that there areapproximately 2-3 million patients in the US who have open-angleglaucoma, a rate of −1.9% for the US population age 40 and older.

Lowering intraocular pressure (IOP) has been the gold-standard totreating glaucoma for over a century. However, very little progress hasbeen made in understanding how the aqueous clearance work in the eye.Recent discoveries in lymphology have shown that the Schlemm's canal isessentially a lymphatic vessel that is key in managing outflow andregulating the IOP. Lymphedema is a condition that results from theimpaired flow of the lymphatics, and Glaucoma is akin to lymphedema ofthe eye′. Similar to other forms of lymphedema, swelling and elevatedpressure is a common side-effect from the build-up of fluid withinadequate clearance.

The standard treatments of glaucoma include IOP-lowering drops,trabeculectomy, or other forms of surgical drainage devices that funnelfluid into various locations (ab-interno vs. ab-externo). Moderate andsevere glaucoma are often treated with combination approaches ofsurgical devices and eye-drops. However, ineffective location ofdevices, ineffective outflow and poor compliance with eye-drops makes itdifficult to address disease progression, especially since glaucoma isan asymptomatic disease.

Pharmacologic approaches for treatment include use of prostaglandin (PG)monotherapy with single agents, carbonic anhydrase inhibitors,prostaglandin analogues, beta-blockers, alpha-2 agonists, etc.Pharmacologic approaches are inadequate in the effectiveness and oftenused as short-term treatments. Compliance remains a large constraint forlong-term effectiveness and prevention of progress. Additionally,side-effects of pharmacologic approach include brow ache, pupilconstriction, burning, and reduced night vision.

Conventional and recent surgical therapies include selective lasertrabeculoplasty (SLT) and microinvasive glaucoma surgery (MIGS). SLT isirreversible and requires ablation of the trabecular meshwork to createoutflow networks. MIGS include a variety of devices that offer a flowchannel for the aqueous fluid outside the eye (ab-externo) or inside theeye (ab-inferno). Ab-interno devices typically reside in the trabecularmeshwork and ab-externo devices typically are trans/sub-conjunctivalplacement.

BRIEF SUMMARY OF THE INVENTION

In a first aspect, the present invention provides a device formaintaining patency of a channel of a uveolymphatic region in the eye orof the Schlemm's canal, referred to interchangeably as a channel,comprising an expansion member consisting of a single elongated elementhaving a bent configuration for radial expansion or support of theuveolymphatic region in the eye or the Schlemm's canal. By “radialexpansion or support,” it is meant that a cross-section or lumen of thechannel of the uveolymphatic region or the Schlemm's canal is held openand available for fluid communication with collector channelssurrounding the uveolymphatic region or the Schlemm's canal to permit orenhance drainage flow from the channel of the uveolymphatic region orthe Schlemm's canal into the collector channels. The expansion member inits bent configuration has (i) sufficient radial strength to withstandcompressive stresses exerted by uveolymphatic region in the eye or theSchlemm's canal and (ii) sufficient void space in its structure tominimize blockage of collector channels in the uveolymphatic region inthe eye or the Schlemm's canal, when the expansion member is implantedin the uveolymphatic region in the eye or the Schlemm's canal. While theexpansion member may optionally be expanded in situ within the channel,as described below, usually the expansion member will be introduced intothe channel in a fully expanded form and open or support the walls ofthe channel as it is advanced forwardly into the channel.

In an exemplary embodiment, a flexible monofilament or single-strandedhelical element, usually a metal wire, such as a nickel-titanium alloy,is formed into a bent, typically helical, geometry with sufficientcross-sectional radial strength (“hoop” strength or crush resistance) toopen and/or support the walls of the channel to allow unveolymphaticfluid flow within Schlemm's canal, and sufficient longitudinalflexibility to conform to a peripheral or arcuate radius of Schlemm'scanal. The single-stranded helical member may comprise a closed distalloop, coil or the like to permit easy insertion and tracking within thecanal, a flexible open pitch intermediate section to permit conformanceto and tenting of the canal along the natural arc of the canal, and atightly pitched or partially opened pitch at a proximal end to permit aporting effect.

While the expansion member will usually “consist of” a single-strandedor other elongated element from other structure, the device may compriseadditional elements and features, such as structures located, coupled,or attached at either or both ends of the single elongated expansionmember for assisting in manipulation or anchoring of the device in theuveolymphatic region and/or in the Schlemm's canal. Such features maycomprise, for example, tubular, helical or other structures located at aproximal end of the single elongated element and configured to extendacross the channel into the anterior chamber to create by-pass for fluidflow. In preferred instances, such features disposed at either of bothends on a single-stranded device will be formed from the single stranditself, e.g., by varying the pitch of a helical filament.

In particular embodiments, the single elongated elements of the devicesof the present invention may comprise a pre-shaped metal or polymericfilament or “monofilament,” where monofilament is defined as a singlestrand of metal or polymer. While such elongated elements, willtypically comprise or consist of a single-stranded, solid core elongatedwire, strand, fiber, or the like, in some instances the elongatedelements might comprise a thread, cord, cable, or the like comprisingmultiple individual strands which are sufficiently tightly wound orotherwise bound together to act as a single solid entity. In specificexamples, the single elongated strand or filament may comprise apre-shaped metal wire, such as a shape or heat memory alloy wire. Inspecific examples, the single elongated element comprises anickel-titanium alloy wire. Exemplary nickel-titanium and other metalwire devices may be formed by drawing the wire into a desired diameterand subsequently heat treating or otherwise forming the wire into adesired helical or other geometry.

The bent configuration of the single elongated element may comprise anyone or combination of curves, loops, twists, turns, corners, kinks,arcs, or other non-linearities along an axial length of the singleelongated elements that define a volume-occupying virtual envelope thatradially supports a wall region of the uveolymphatic region in the eyeor the Schlemm's canal when implanted therein. This virtual envelopewill typically be generally cylindrical but could have other shapes aswell. In specific examples, the single elongated element its bentconfiguration is at least partially formed with repeating helical turns.In other examples, the single elongated element in its bentconfiguration is at least partially formed with repeating serpentineloops.

In specific instances, the single elongated element may be curved alongits length in its bent configuration when free from constraint,preferably conforming to a shape of the uveolymphatic region in the eyeor the Schlemm's canal. In other instances, the at least one end of thesingle elongated element may have a geometry different than that of theremainder of the single elongated element, often having both ends with ageometry different than that of a central region of the single elongatedelement. The geometries at the ends may differ in only dimensions, e.g.being helical with a different wire diameter, helical diameter, and/orpitch or may differ in shape, e.g. being loops terminating either orboth ends of the single elongated element.

Exemplary and preferred dimensions for shape memory helical wireembodiments of the single elongated element in its bent configurationare set forth in Table I.

TABLE I Broad Range Medium Range Preferred Range (mm) (mm) (mm) WireDiameter 0.0001 to 1 0.01 to 0.15 0.05 to 0.1 Helical Pitch 0.0001 to 100.1 to 2 0.15 to 1 (Distance between successive turns of the helixmeasured at midpoints of each turn) Helical Diameter 0.0001 to 10 0.05to 1 0.2 to 0.4 (Measured at across outside of helical region of bentwire structure)

In further specific instances, at least one end of the single elongatedelement is formed into or otherwise comprises a tubular structure ormember, such as a helix having a tighter pitch and smaller diameter thanthose of the central region. Often both ends of the single elongatedelement will be formed into a helix having a tighter pitch and smallerdiameter than those of the central region, wherein tighter pitch istypically in a range from 0.001 mm to 1 mm, usually from 0.01 mm to 0.2mm, and preferably from 0.05 mm to 0.15 mm, and the smaller diameter isin a range from 0.001 mm to 1 mm, usually from 0.05 mm to 0.4 mm, andpreferably from 0.1 mm to 0.3 mm.

In further embodiments of the device for maintaining patency of thepresent invention, the single elongated element may comprise any one ormore of a variety of features, such as a radius of curvature selected tomatch that of the radius of curvature of the uveolymphatic canal or theSchlemm's canal of the eye. The single elongated element will alsotypically be polished via mechanical, chemical or electrochemicalmethods to improve finish and biocompatibility. The single elongatedelement may at least one end formed in a loop. The single elongatedelement may have at least one end formed as a tightly wound coil. Thesingle elongated element may comprise at least one feature at at leastone end thereof configured to facilitate manipulation. The singleelongated element may be at least partially biodegradable orbioresorbable. The single elongated element may comprise a drug-elutingmember formed on a surface thereof or embedded therein. The singleelongated element may comprise of hydrophilic or hydrophobic coating toaid in the safety and efficacy of the device within the eye. The singleelongated element may include a by-pass feature configured to permitaqueous flow between Schlemm's canal and an anterior chamber of the eye,where the by-pass feature may locate at an entry, an exit, or along alength of the device.

In a second aspect, the present invention provides method of treatingglaucoma in a patient. The method typically comprises implanting anexpansion member consisting of a single elongated element in anuveolymphatic channel or a Schlemm's canal of the patient. The singleelongated element, when implanted, opens the uveolymphatic channel orthe Schlemm's canal of the patient with (i) sufficient radial strengthto withstand compressive stresses exerted by uveolymphatic region in theeye or the Schlemm's canal and (ii) sufficient void space in itsstructure to minimize blockage of collector channels in theuveolymphatic region in the eye or the Schlemm's canal, when theexpansion member is implanted in the uveolymphatic region in the eye orthe Schlemm's canal.

In specific examples of these methods of treating glaucoma of thepresent invention, the single elongated element typically has a bentconfiguration when implanted, where the term bent has been definedpreviously. Alternatively, the methods may further comprise introducinga delivery tube into the uveolymphatic channel or a Schlemm's canal ofthe patient and releasing the expansion member from constraint so thatthe single elongated element radially expands in situ. In either case,the single elongated element typically comprises a pre-shaped metal orpolymeric filament but could also comprise any of the filamentsdescribed above.

In preferred aspects of the methods of the present invention, the singleelongated element in its bent configuration is at least partially formedwith repeating helical turns or with the single elongated element in itsbent configuration is at least partially formed with repeatingserpentine loops. Usually, the single elongated element is curved alongits length in its bent configuration when free from constraint toconform to the shape of the uveolymphatic region in the eye or theSchlemm's canal. Often, the at least one end of the single elongatedelement has a geometry different than that of the remainder of thesingle elongated element, and frequently both ends of the singleelongated element have a geometry different than that of a centralregion of the single elongated element.

In further instances of the methods herein, the radius of curvature ofthe single elongated element matches that of the radius of curvature ofthe uveolymphatic canal or the Schlemm's canal of the eye. The radius ofcurvature of the single elongated element may be selected to cause aninward or outward bowing of the uveolymphatic canal or the Schlemm'scanal of the eye. An end of the single elongated element may bepositioned to collapse Schlemm's canal to allow flow between Schlemm'scanal and the trabecular meshwork.

The methods herein may further comprise additional aspects, such aseluting a drug from the single elongated element. The single elongatedelement may comprise a hydrophilic or hydrophobic coating to aid in thesafety and efficacy of the device within the eye. The single elongatedelement may be positioned into an anterior chamber to provide aqueousflow at an entry, an exit, along a length of the device, into or out ofthe canal, or to or from the anterior chamber of the eye. The singleelongated element may be implanted using fluorescence or image-guidedsurgery to avoid blockage of collector channels within the uveolymphaticcanal or the Schlemm's canal of the eye. The single elongated elementmay be implanted with aid from expandable member comprising of balloonor aspiration.

Yet further specific aspects of the methods herein include customizingthe single elongated element based on a preoperative intraocularpressure IOP and desired regulation or decrease in intraocular pressure(IOP). The single elongated element may be able to deliver energy totransform the shape of the device or that of the nearby tissue.

The methods herein further comprise a variety of deliver options. Thesingle elongated element may be delivered with a tool comprising adevice channel comprising an outer sheath and an inner member, thedevice configured to be disposed between the inner member and the outersheath, the delivery tool comprising a locking member configured toreversibly lock the device within the device channel. The singleelongated element may be delivered with access from the angle inside theanterior chamber, or outside the eye from the sub-conjunctival region orthe limbus region or the scleral region of the eye. The single elongatedelement may be delivered with assist from dying or visualization toaccess the canal of the eye in a minimally invasive manner. The singleelongated element may be delivered with a delivery tool that has apressured system to control the delivery of the device into the eye. Thesingle elongated element may be delivered with a delivery tool that isassisted with a visualization scope or imaging. The single elongatedelement may be delivered with a delivery tool is attached to a syringe.The single elongated element may be delivered with a delivery tool thathas a temperature control to manipulate the physical state of the devicebefore, during and after delivery. The single elongated element may bedelivered with a delivery tool that incorporates sliders or plungers ormay be controlled using torsional or axial contact boards or contactrollers. The single elongated element may be delivered with a deliverytool that can also provide the incision required to enter theuveolymphatic vessel or canal. The single elongated element may bedelivered with a delivery tool that can provide an expansion channel toreduce friction in delivery the device. The single elongated element maybe delivered with a delivery tool that pre-tighten or wind-up thedevice. The single elongated element may be delivered with a deliverytool that may be powered by a piezo-electric or vibrational motor. Thesingle elongated element may be delivered with a delivery tool that mayutilize a use a guidewire to deliver, position, re-position or retractthe device.

In some embodiments, the single elongated element may at least partiallycomprise a polymeric material selected from a group consisting ofpolyvinylidene fluoride, polyvinylidene difluoride (PVDF),polyvinylpyrrolidone (PVP), polyurethane, polyethylene glycol (PEG),polylactic acid (PLA), polycaprolactone (PCL), polyglycolic acid (PGA),polymethylmethacrylate (PMMA), polyacrylates, polyamide, polyimide,polyesters, silicone, carbon-composites, and the like. Such materialsmaybe used in substantially pure form or as mixtures or composites withother materials.

In some embodiments, the single elongated element may at least partiallycomprise at least one metal or alloy selected from a group consisting oftitanium, stainless steel, cobalt-chrome alloy, gold, platinum, silver,iridium, tantalum, tungsten, aluminum, vanadium, and the like.

Some embodiments of the invention are directed to minimally invasivesystems and methods for treating glaucoma, by utilizing one, two, ormore adjustable shape memory canal tension rings (or stents) configuredto be placed within the canal of the uveolymphatic vessel or theSchlemm's canal. The tension ring(s) exert a radially outward mechanicalforce on the canal to restore the patency of the canal and improveaqueous flow therethrough, typically although not exclusively in anon-penetrating fashion. The rings can include a proximal end, distalend, and a coiled section comprising a plurality of revolutionstherebetween, and proximal and distal eyelets for ease in manipulation,relocation, or retraction using a separate insertion or retrievingdevice. The coiled section has a variable outer diameter along itslength. The rings can be made of a small diameter shape memory wire ortube (e.g., about 5-30 μm wire diameter and 150-500 μm device outerdiameter), such as shape-memory alloy (SMAs), flexible metals such asstainless steel, titanium, etc. and flexible polymers including shapememory polymers (SMPs), silicone, polyvinylidene fluoride (PVDF),polymethylmethacrylate (PMMA), polypropylene (PP), polyethersulfone(PES), poly-lactic acid (PLA), poly-glycolic acid (PGA), and tunablebiodegradable polymers, drug-eluting, shape memory alloys (nitinol,etc.).

Some embodiments of the invention advantageously leverage the expansionof the uveolymphatic vessel or the Schlemm's canal using adjustable andreversible self-expanding eye stents (SESs) or eye tension rings (ETRs)in the eye of desired sizes to control and improve flow throughout therange of the canal. As such, some embodiments include an adjustabletension ring(s) or cylinders that sits at least partially within thecanal and/or is partially or fully anchored, attached, adhered, orotherwise held in place with respect to the canal opening or otherlocations within the canal and/or elsewhere in the uvea. The expansionof the canal can be configured to change at the various zones within theSchlemm's canal independently and based on the patient specific needs.In some embodiments, the tension rings may be 1, 2, 3, 4, 5, 6 separaterings of various sizes. In some embodiments, the system can beconfigured to control the flow rate of aqueous through the canal. Insome embodiments, the rings can be substituted by cylinders, includingsome with fixation elements. The Adjustable reversible eye tension ringscan be configured to fit a specific patient's range in canal dimensionsin some embodiments.

In some embodiments, the adjustable reversible self-expanding eye stents(SESs) or eye tension rings (ETRs) could include one, two, or morefixation elements. The fixation elements can promote fixation of the SESto the canal wall. In some embodiments, the SES may include a protrusionor indentation for stabilizing and/or fixing the SES at the wall. Thefixation elements can also include sub-elements to anchor the SES to thewall, for example, grooves, teeth, ridges, or a saw-tooth pattern, forexample. In some embodiments, two or more of the same or differentfixation elements can be used in combination.

In some embodiments, the SES can include one or many features such asgrooves or loops to allow easy capture and removal of the SES, if/whenneeded.

Also disclosed herein are various materials for the SES including:shape-memory alloy (SMAs), flexible metals such as stainless steel,titanium, etc. and flexible polymers including shape memory polymers(SMPs), silicone, polyvinylidene fluoride (PVDF), polymethylmethacrylate(PMMA), polypropylene (PP), polyethersulfone (PES), poly-lactic acid(PLA), poly-glycolic acid (PGA), and tunable biodegradable polymers,that can be implanted through a small incision and spring back to theoriginal configuration without damage. In some embodiments, the SESmaterial may include coatings to prevent degradation and encrustation.The coating might be of hydrophobic or hydrophilic in nature such assilicone or polytetrafluoroethylene, or other lubricious coating. Insome embodiments, the SES may include a drug-eluting coating on thesurface or in the matrix/bulk to further promote healing of the eye.

In some embodiments, disclosed is a method of surgically implanting theSES. A delivery system may contain a cannula for incision into thechannel and a trigger mechanism to deploy the SES with each click orturn. The SES can be preloaded for the various sizes into a cartridgewhich can be attached to the delivery system. The advantage of such atechnique is to accurately position the SES to deploy in the appropriatezones within the canal. The SES can be implanted via a placement toolallowing use of the manipulating features which can also be used toeasily relocate or retract in some cases. The SES could be implantedalone, or in combination with other SES in some embodiments.

The SES can be customized for a specific patient, including age, race,demographic, predispositions, canal dimensions, anatomical differences,and other factors unique to the patient. The SESs can also be customizedbased on the patient's baseline IOP or desired IOP reduction by choosingthe length and width of the SES and control dilation, and hence theaqueous outflow. Due to the unique features of the SES device and thedelivery technique, the device may offer several advantages includingmaximum dilation of the canal with the material presence within thecanal, non-blockage of the lymphatic draining/collector channels foradequate drainage, nano/micro incision surgery with the least amount ofmaterial interaction with tissue, and complete reversibility.

In some embodiments, a device can include any combination of thefollowing features, or others as disclosed herein:

An adjustable self-expanding eye stent (SES) or Eye Tension Ring (ETR)embodiment stored and loaded into a delivery system, once deployed thestored embodiment will spring and take shape with its shape memory andform a tension or torsion ring or rings that is inside or outside thecanal wall and is larger than the canal diameter, providing separationbetween the previously compressed canal of the Schlemm's canal oruveolymphatic vessel any animal. One or more embodiments with varyingsizes can be deployed in the compressed canal at various locations. Theembodiments can be a combination of smaller diameter at the ends andlarger diameter in the middle (to anchor and prevent migration) or thesame SES can contain these variations.

An SES made of round/rectangular/square polymer or metal or alloywire/tubing. The wire tubing OD can be between 0.0005″ to 0.10″. Thenon-circular wire embodiment can be between 0.0005″-0.10″×0.0005″-0.10″

An SES shaped to match the radius or arc of the perimeter of the globeor uveolymphatic canal path. In some embodiments, the shape may exert nobowing or contracting of the canal. In some other embodiments the shapemay have an inward bowing of the canal.

An SES with shallow or variable pitch across the length of the SES. Thepitch of a helical SES may vary from 0.00005″ to 0.10″. In someembodiments, the tighter pitch can be either on the proximal end, ordistal end or both. In some embodiments, the wider pitch can be eitheron the proximal end, or distal end or both.

An SES with a rigidity that permits it to be pushed linearly intoSchlemm's canal without losing its integrity/without deforming.

An SES where the distal and proximal ends are open. In some embodiments,the SES may have one or more coils that are welded together to form aclosed loop at any point or points along the length, or ends, of theSES. In some other embodiments, the SES pitch of the distal end,proximal end, or both ends, are shallow such that the coil comes back onitself to form a closed loop. In some other embodiments, the SES'sproximal end, or distal end, or both are welded to the preceding orsubsequent coil to complete a loop.

An SES where one end, or both ends, of the SES are wound tightly suchthat Schlemm's canal is collapsed by the tightly wound coils therebyallowing flow between Schlemm's canal and the trabecular meshworkthrough the tightly wound coils and down the length of the tightly woundportion or portions.

An SES comprising of various perforations and extensions to anchor tothe canal wall.

An SES comprising a plurality of perforations or features to allow rapidexchange, repositioning, or removal.

An SES designed and selected based on patient specific IOP throughpre-operative measurement.

An SES designed with irregularities on the peripheral circumferenceincluding ridges, indentations, etc. to allow better anchoring andpreventing migration.

An SES implanted in the same operative procedure as positioning anotherSES in the Schlemm's canal of the patient.

An SES designed to vary the sweep between 10 to 360 degrees.Additionally, the SESs may have multiple continuous or dis-continuoussweeps from 1 to 10.

An SES used in multiples and with various sizing within the canal tocontrol the shape of the expansion and amount and direction flow.

An SES where the SESs can be customized for a specific patient oranimal, including age, race, demographic, genetic predispositions, canaldimensions, Schlemm's canal dimensions, intraocular pressure (IOP)measurements, anatomical differences in the eye, and other factorsunique to the patient or animal.

An SES where the SES is a tension ring which can be customized to shrinkand/or lengthen upon adjusting the manipulating feature of the SES, forsafe and easy relocation, repositioning or removal.

An adjustable self-expanding eye stent (SES) or an Eye Tension Ring(ETR) embodiment stored and loaded into a delivery system, once deployedthe stored embodiment will spring and take shape with its shape memoryand form a tension or torsion ring or rings that is inside or outsidethe canal wall and is larger than the canal diameter, providingseparation between the previously compressed canal of the Schlemm'scanal in the body of any animal. A balloon catheter or incision cannulamaybe deployed prior to the deployment of the SES to allow enlargementof the Schlemm's canal allowing the SES to be deployed with ease.

An SES where the SES has a sharp leading edge or cannula that can piercethe canal wall to anchor and keep it expanded from outside the canalwall.

An SES where the SES has a manipulating feature that is anchored insidethe canal wall to allow subsequent manipulating of the SES.

An SES where the SES can be delivered in a shrunken (or smaller) stateby manipulating temperature of the SES using external energy(electrical, mechanical, thermal, RF, light, etc.)

An adjustable self-expanding eye stent (SES) or an Eye Tension Ring(ETR) embodiment that can be manipulated by an insertion tool whosetemperature can be externally controlled through an energy source(electrical, mechanical, thermal, RF, light, etc.), such that it canalter the shape (shrink or expand) of the SES to make insertion orretrieval procedure both minimally invasive, responsive, and easy tomanipulate/handle.

An SES comprising an extruded metal or plastic tubing may be stored in afirst state, and once the SES is deployed to the desired location, theSES takes shape with its shaped memory and configuration.

An SES comprising an extruded metal or plastic tubing whereby theextruded metal or plastic tubing is printed with measurement markers toserve as a reference point in SES deployment.

An SES with a cannula and/or balloon at the distal end which canfacilitate opening of the Schlemm's canal and anchoring from the canalincision/opening to accurately deploy and position the SES.

An SES which a user can feel being incrementally advanced towards thedistal shaft as guided by the delivery device. The deployment mechanismcan be conveyed from the handle of the device. The deployment mechanismcan be geared so that the advancement is measured based on thepredetermined measured location.

A stapler-type device where the SES is stored in a cartridge containinga predetermined count such as 1 to 6 SES's with single SES'sindividually dispensed from the cartridge via a trigger mechanism fromthe handle of the SES delivery system.

An SES delivery system having the SESs pre-loaded into multiplecartridges allowing deployment of all SESs in one single procedureminimizing time needed.

An SES delivery system which can be either manually via pushercatheter—shaft/tubing; or mechanically driven e.g., staple; orelectromechanically delivered into the desired location; and or energydriven i.e. radio frequency, or electronic signal.

An SES that may have features such as a loop, hook, or eyelets to alloweasy capture using an SES retrieval system that can allow the SES tocompress and withdraw into the system in cases where repositioning orremoval is desired.

An SES can be withdrawn by compression or re-folding the embodiment backinto a linear or FIG. 8 shape and either fully withdrawn or reposition.

The SES can be withdrawn by capturing the manipulating feature of theSES and re-winding into a track/guide.

An SES that can be withdrawn by capturing the manipulating feature andshrinking the SES by manipulating temperature of the SES using externalenergy.

SES delivery systems and SES retrieval systems that have polymericcoatings including fluoropolymers and silicone, etc. The coatings mayalso be used to seal and prevent coagulation, debris accumulation, ordegradation over time.

An SES can be deployed using a tool and/or mechanism to hold bothsections of the SES align with the axis of the SES. After which the SESis repositioned by turning the SES perpendicular to the deployed axis.

An SES with customized sizing based on biometry of the Schlemm's canalspace. The Schlemm's canal may be measured or imaged as a pre-operativescan using various qualitative or quantitative measurement tools todetermine the customized fit of SES size(s) required for the specificpatient's need. Biometric measurements including Schlemm's canaldimensions, Schlemm's canal angle, cross-sectional area (CSA), may beused to determine and customize the SES design to fit the specificphysiological and anatomical need of the patient.

An SES with customized sizing based on intraocular pressure reading orbiometry of the eye. The IOP can be used to determine the customized fitof SES size(s) required for the specific patient's need or requiredreduction of IOP.

As the patient ages and as canal and Schlemm's canal undergoesphysiological changes, the SES may be replaced (with other sizes ortensile strength) to fit the changing need.

A device for maintaining patency of a uveolymphatic region in the eye orthe Schlemm's canal, comprising: a self-expanding shape memory membercomprising a proximal end, a distal end, and a passageway therebetweenconfigured to facilitate flow of body fluids therebetween, the shapememory member further comprising a plurality of partial or completeloops between the proximal end and the distal end, the shape memorymember comprising a central portion and lateral portions, wherein thecentral portion comprises a first diameter and the lateral portionscomprise a second diameter, wherein the first diameter is not equal tothe second diameter, wherein the shape memory member further comprises afirst radially compressed configuration transformable to a secondradially enlarged configuration.

Such a device wherein the first diameter is larger than the seconddiameter.

Such a device, wherein the first diameter is smaller than the seconddiameter.

Such a device wherein the central portion has a generally constant firstdiameter throughout the entire length of the central portion.

Such a device wherein the lateral portions have a generally constantsecond diameter throughout the entire length of the central portion.

Such a device, wherein non-adjacent loops of the device are onlyconnected to each other via directly adjacent loops.

Such a device, wherein the shape memory member has a diameter of betweenabout 0.0005″ and about 0.050″.

Such a device wherein the shape memory member has a non-circular crosssection, the cross-section having a major axis and a minor axis, whereinthe minor axis dimension is between about 0.0005″ and about 0.050″.

Such a device wherein the radius of curvature of the device matches thatof the radius of curvature of the uveolymphatic canal in the globe.

Such a device wherein the radius of curvature of the device may have aninward or outward bowing of the canal.

Such a device wherein the proximal end of the device may have a pitchdimension between 0.0005″ and about 0.050″.

Such a device wherein the distal end of the device may have a pitchdimension between 0.0005″ and about 0.050″.

Such a device wherein the main body of the device may have a pitchdimension between 0.0005″ and about 0.050″.

Such a device wherein the proximal and/or distal end of the device mayhave a smaller pitch in comparison to the main body.

Such a device wherein the proximal and/or distal end of the device mayhave the coil ending in the same plane as a closed loop finish.

Such a device wherein the proximal and/or distal end of the device maybe polished via mechanical, chemical, or electrochemical methods.

Such a device wherein the proximal and/or distal end of the device maybe welded to the preceding or subsequent coil to complete a loop.

Such a device wherein one end, or both ends, of the device are woundtightly such that Schlemm's canal is collapsed by the tightly woundcoils thereby allowing flow between Schlemm's canal and the trabecularmeshwork through the tightly wound coils and down the length of thetightly wound portion or portions.

Such a device further comprising one or more manipulation featuresproximate at least one of the proximal ends and the distal end.

Such a device wherein the one or more manipulation features are selectedfrom the group consisting of an eyelet, a hook, and a loop.

Such a device wherein the one or more manipulation features are selectedfrom the group consisting of an eyelet, a hook, and a loop.

Such a device, wherein the manipulation features are used for anchoringinto the canal.

Such a device wherein the shape memory member comprises a biodegradablepolymer with controlled resorption into the eye.

Such a device wherein the shape memory member comprises a drug-elutingmember coated on the surface or embedded into the bulk for controlledrelease into the eye.

Such a device wherein the shape memory member comprises a hydrophobiccoating.

Such a device wherein the shape memory member comprises a hydrophiliccoating.

Such a device wherein the proximal end comprises a sharp edge configuredto pierce the canal wall to anchor into the canal wall itself and keepit expanded from outside the canal wall.

Such a device, wherein the shape memory member comprises surfaceirregularities configured to promote anchoring and/or prevent migration.

Such a device wherein the surface irregularities comprise one or more ofridges, roughened surface, pores, and indentations.

Such a device comprising between about 1 and about 100 partial orcomplete loops.

Such a device wherein the device has by-pass and/or dilating feature(s)at the entry or exit or along the length of the device, into or out ofthe canal to/from the anterior chamber.

Such a device wherein the device has by-pass features into the anteriorchamber for aqueous flow at the entry, or exit or along the length ofthe device, into or out of the canal to/from the anterior chamber.

Such a device, wherein the device has elongated diameter in certainsections where by-pass and/or dilating feature(s) are desired, at theentry or exit or along the length of the device, into or out of thecanal to/from the anterior chamber.

Such a device wherein the device may be implanted using fluorescence orimage-guided to avoid blocking of collector channels within the canal.

Such a device wherein the device may be a wire shaped to variousconfigurations to self-expand in the canal and maintain patency.

Such a device wherein the device may be of specific dimensions in outerdiameter, pitch, wire diameter, and shape to accommodate the requiredtension needed within the canal.

Such a device, assisted by finite element modeling for selective patientpopulation groups.

Such a device, wherein the device has a polymeric sheath along thelength of device in a continuous or non-continuous manner.

A delivery system comprising a such a device and a delivery toolcomprising a device channel comprising an outer sheath and an innermember, the device configured to be disposed between the inner memberand the outer sheath, the delivery tool comprising a locking memberconfigured to reversibly lock the device within the device channel.

Such a delivery system wherein the delivery may be accessed from theangle inside the anterior chamber, or outside the eye from thesub-conjunctival region or the limbus region or the scleral region.

Such a delivery system assisted with dying or visualization to accessthe canal in a minimally invasive manner.

Such a delivery system, wherein the delivery tool comprises a scope orvisualization.

Such a delivery system wherein the delivery tool has a pressured systemto control the delivery of the device.

Such a delivery system wherein the delivery tool is attached to asyringe.

Such a delivery system wherein the delivery tool has a temperaturecontrol to manipulate the state of the device before, during and afterdelivery.

Such a delivery system wherein the inner, outer members and the devicemay be controlled using sliders or plungers.

Such a delivery system wherein the inner, outer members and the devicemay be controlled using torsional or axial contact boards.

Such a delivery system wherein the inner, outer members and the devicemay be controlled using torsional or axial contact rollers.

Such a delivery system wherein members may provide the incision requiredto enter the uveolymphatic vessel or canal.

Such a delivery system wherein it may have an un-coiler channel toreduce friction in delivery the device.

Such a delivery system wherein it may pre-tighten or wound-up thedevice.

Such a delivery system where it may be powered by a piezo-electric orvibrational motor.

Such a delivery system, where it may use a guide-wire to deliver thedevice.

Such a delivery system where it may use a guide-wire to reposition orretract the device.

A method of treating glaucoma in a patient, comprising expanding theuveolymphatic channel or the Schlemm's canal in the patient using anexpandable member, radially expanding at least one device comprising ashape memory member comprising a plurality of windings within the canalof the Schlemm's canal to expand the diameter of the Schlemm's canal, atleast one device comprising a larger diameter portion and a smallerdiameter portion, the larger diameter portion providing a radial forceagainst the Schlemm's canal sufficient to maintain patency of theSchlemm's canal, and unlocking a manipulation feature of the at leastone device from a delivery tool.

Such a method wherein the expandable member comprises a balloon.

Such a method comprising radially expanding a plurality of devices.

Such a method wherein the plurality of devices is radially expandedsequentially.

Such a method wherein the plurality of devices comprises varying sizesand/or shapes.

Such a method, further comprising removing the delivery tool from theSchlemm's canal.

Such a method wherein the delivery tool comprises a scope comprising adevice channel, an outer sheath, and an inner member, wherein the deviceis disposed between the inner member and the outer sheath and in aradially compressed configuration during delivery.

Such a method further comprising axially moving the outer sheathrelative to the device to allow the device to radially expand.

Such a method wherein following radially expanding the at least onedevice within the canal of the Schlemm's canal, no more than about 25%of an entire surface area of the device is exposed to aqueous flowwithin the Schlemm's canal.

Such a method wherein the shape memory member has a maximum diameter ofless than about 0.050″.

Such a method wherein the device once implanted does not extend axiallyoutside of the Schlemm's canal.

Such a method further comprising delivering energy to the at least onedevice to transform the size and/or shape of the device.

Such a method, wherein the at least one device is custom created basedon biometry of the patient's Schlemm's canal.

Such a method wherein the at least one device is custom created based onmeasured patient parameters selected from one or more of pre-operativeimaging, Schlemm's canal dimensions, Schlemm's canal cross-sectionalarea, Schlemm's canal perimeter.

Such a method wherein the at least one device is custom created based onmeasured patient preoperative intraocular pressure IOP and desiredregulation of IOP.

A method of treating glaucoma in a patient, comprising dilating orby-passing the uveolymphatic channel or the Schlemm's canal in thepatient using an expandable member, radially expanding at least onedevice comprising a shape memory member comprising a plurality ofwindings within or across the Schlemm's canal to provide by-pass and/orexpansion into the diameter of the Schlemm's canal, at least one devicecomprising a larger continuous diameter portion and a smaller diameterportion, the larger diameter portion providing a radial force againstthe Schlemm's canal sufficient to maintain patency of the Schlemm'scanal.

Such a method wherein the device has by-pass and/or dilating feature(s)at the entry or exit or along the length of the device, into or out ofthe Schlemm's canal to/from the anterior chamber.

Such a method wherein the device has by-pass feature(s) at the entryand/or exit or along the length of the device, into or out of theSchlemm's canal to/from the anterior chamber at the wound and/orincision.

Such a method wherein the device has by-pass feature(s) at the entryand/or exit or along the length of the device, along the same perimetricplane of the Schlemm's canal away from the anterior chamber at the woundand/or incision.

Such a method where one end, or both ends, of the device are woundtightly such that Schlemm's canal is collapsed by the tightly woundcoils thereby allowing flow between Schlemm's canal and the trabecularmeshwork through the tightly wound coils and/or down the length of thetightly wound portion or portions.

Such a method where one end, or both ends, of the device are woundportion or portions protrude through the wall of canal into thetrabecular meshwork such that flow between canal and trabecular meshworkis enabled through the tightly wound coils and/or down the length of thetightly wound portion or portions.

Such a method, wherein the device has a polymeric sheath along thelength of device in a continuous or non-continuous manner.

A method of repositioning or removing a device for treating glaucoma ina patient, comprising delivering an effector tool proximate theSchlemm's canal and a previously implanted device residing within thecanal of the Schlemm's canal, wherein a previously implanted devicecomprises one or more shape memory member comprising a plurality ofwindings, the windings forming a canal with a variable inner diameter,the device maintaining the patency of the canal of the Schlemm's canal,contacting a manipulation feature of the previously-implanted devicewith the effector tool, locking the manipulation feature of the at leastone device; and removing or repositioning the device.

Such a method further comprising delivering energy from the effectortool to the manipulation feature to change the size and/or shape of thedevice.

Such a method wherein the manipulation feature comprises a hook, a loop,a magnet, or a threaded feature.

Such a method wherein the manipulation feature comprises a hook, a loop,a magnet, or a threaded feature.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an isometric sketch of the eye with a labelindicating the location of the Schlemm's canal or the uveolymphaticvessel.

FIG. 2 illustrates a cross-sectional sketch of the eye with labelsindicating aqueous humor flow from the posterior chamber ciliary body tothe trabecular meshwork and into the Schlemm's canal.

FIG. 3A shows a cross-sectional stained micrograph of the human eye withthe Schlemm's canal's location clearly labeled.

FIGS. 3B-3D show detailed developmental cellular schematics of theuveolymphatic vessel, including how the aqueous humor outflow occurs.

FIG. 4A illustrates an isometric sketch of the eye with a variant of theself-expanding eye stent (SES) device in a helical form dilating theuveolymphatic vessel or Schlemm's canal

FIGS. 4B and C illustrate variant of the SES device in a helical formwith the manipulating features and tension rings in axially expanded andcontracted configurations.

FIGS. 5A and 5B contain variants of the self-expanding eye stent (SES)device in a helical form with the manipulating features and tensionrings. FIG. 5A contains a variant of the SES device where the centralportion of the tension ring is larger in diameter than the peripheralends.

FIG. 5C contains a variant of the SES device where the central portionof the tension ring is smaller in diameter than the peripheral ends.

FIG. 6A illustrates a variant of the self-expanding eye stent (SES)device where the device is connected by a structural feature holding themultiple tension rings.

FIG. 6B illustrates a variant of this SES device dilating theuveolymphatic vessel or Schlemm's canal.

FIG. 7A illustrates a variant of the self-expanding eye stent (SES)device where the device is a single tension ring with a manipulatingfeature.

FIG. 7B illustrates a variant of this SES device dilating theuveolymphatic vessel or Schlemm's canal in multiple locations within thecanal.

FIGS. 8A and 8B illustrate variants of the self-expanding eye stent(SES) device where the device has variable pitch with an entry by-passfeature and a manipulating feature.

FIG. 8C illustrates a variant of this SES device dilating theuveolymphatic vessel or Schlemm's canal while the by-pass feature iswithin or through the canal wall.

FIGS. 9A-9D illustrate variants of the SES device where the device hasvariable pitch with a double entry by-pass features and manipulatingfeatures.

FIG. 9E illustrates a variant of this SES device dilating theuveolymphatic vessel or Schlemm's canal while by-pass features at eitherend are within or through the canal walls.

FIGS. 10A-10F illustrates variants of the SES device where the devicehas variable pitch along the free length of the helical coil of the SES.

FIGS. 11A-11J illustrates variants of the SES device where the devicehas variable shapes and sizes along the free length of the helical coilof the SES.

FIG. 12 illustrates a variant of the SES device where the manipulationfeature allows a hook-loop to reposition or retrieve the SES.

FIGS. 13A and 13B illustrate a variant of the SES device where thehelical coil has a polymeric sheath at the entry or exit or through thelength of SES allowing regulation of flow into the canal.

FIG. 14 illustrates a variant of the SES device where the device is adouble helical coil with manipulation features.

FIG. 15 illustrates a graph demonstrating the correlation of the aqueousflow (and hence change in intraocular pressure or IOP) as a function ofthe SES diameter and length.

FIG. 16A are photographic images of the SES device made withshape-memory alloys and polymeric materials.

FIGS. 16B and 16C are photographic images of the SES device in-situ inthe uveolymphatic vessel adequately dilated.

FIG. 17 illustrates a cross-sectional view of the eye, with indicationsfor various locations of possible insertion of the SES device into theuveolymphatic vessel.

FIGS. 18A-18C illustrates a variant of an SES delivery device containingan outer cannula that houses an inner cannula that in turn houses theSES device. Sliders to move the cannulas and the device are highlighted.

FIGS. 19A-19C illustrate a variant of an SES delivery device in-situaccessing the uveolymphatic vessel using the inner and outer cannula.The SES device delivery from the inner cannula is also shown.

FIG. 20 illustrates a variant of an SES delivery device that utilizes apositive pressure system to control the advancement, deployment, andretraction of the SES device.

FIG. 21 illustrates a variant of an SES delivery device that utilizes apositive pressure system to control the advancement, deployment, andretraction of the SES device.

FIGS. 22A and 22B illustrate a variant of an SES delivery device thatutilizes a multiple contact system similar to a feather-board to controlthe advancement, deployment, and retraction of the SES device.

FIGS. 23A and 23B illustrate a variant of an SES delivery device thatutilizes a lead guidewire that can selectively attach/detach to the SESdevice to control the advancement, deployment, and retraction of the SESdevice.

FIGS. 24A-24C illustrate a variant of an SES device and delivery systemthat utilizes a guide-wire to control the advancement, deployment, andretraction of the SES device.

FIG. 25A illustrates a variant of a curved and electropolished SESdevice with wide pitch along the length of the device and a tighterfinished closed loop ends.

FIGS. 25B and 25C illustrate closer view of the proximal and distal end,respectively.

FIG. 26A illustrates a variant of a curved and electropolished SESdevice in situ in the uveolymphatic canal.

FIG. 26B illustrates a variant of a curved and electropolished SESdevice in situ in the uveolymphatic canal with the proximal end extendedacross the channel into the anterior chamber to create by-pass for fluidflow.

FIGS. 26C and 26C1-1 illustrate a variant of a curved andelectropolished SES device in situ in the uveolymphatic canal with theproximal end extended along the same plane as the channel to create acollapsed wound opening and by-pass for fluid flow.

FIG. 26D contains a perspective closer view of the proximal end by-passvariant.

FIG. 27 illustrates a variant of a slide-inserted device to deploy theSES and a detailed exploded view of such a delivery system.

DETAILED DESCRIPTION OF THE INVENTION

Several factors influence the onset and progression of glaucoma asdiscussed in previous sections. The critical region where aqueousdrainage occurs is in the uveolymphatic vessel or Schlemm's canal. Whenthis region is blocked or constricted, it creates a cascading effect ofinflammation that includes edema or elevation of intraocular pressure.Dilating and/or creating by-pass flow for the uveolymphatic vessel orSchlemm's canal allows for continuous and regulated clearance of theaqueous humor, which restores the lymphatic function of the eye andhence regulates the intraocular pressure.

Disclosed herein are adjustable self-expanding eye stent (SES) orreversible eye tension rings (ETRs) embodiments that can be configuredto adjust the diameter and opening of the Schlemm's canal. SESs caninclude various generally prosthetic devices, including tubular membersconfigured to maintain or improve the patency of at least a portion ofthe uveolymphatic vessel, such as the Schlemm's canal 400. In someembodiments, a device can improve the patency of the Schlemm's canal,but not other uveal regions.

Disclosed herein are methods for deploying prosthetic devices, includingfixed canal or adjustable self-expanding eye stent (SES) or reversibleeye tension rings (ETRs) 401 using an expandable member, such as aballoon technique, expandable device (e.g., movable cage with struts).In some embodiments, the leading edge of the delivery device for the SESor a cannula can create an entry incision 402 such that the SES 401 canbe delivered in a folded state. Once inside the canal 400, the SES 401can be fully deployed and uncoil in-situ, as shown in FIG. 4A. The SES401 may contain one or more manipulation features 403 such that they canbe used to adjust, reposition, and retrieve to/from and within theuveolymphatic vessel. In some embodiments, the deployment of the SES 401can be controlled by a spring-loaded plunger or threaded screw typetool. Some embodiments of the SES 401 can be deployed into the balloonexpanded canal, such that it anchors or keeps the canal expanded andaway from collapse. In some embodiments, multiple SESs 401 can bedeployed in various locations within the canal 400 and allow regulationof the flow through controlled dilation along the length of the canaland/or by-pass of fluid within the canal.

Disclosed herein are manipulation features 403 contained within thedevices, such as SES 401. In some embodiments, the SES 401 can includeone, two, or many manipulating features 403 such as barbs, grooves orloops to allow easy anchoring, capture, re-alignment, re-positioning andremoval of the SES 401, if/when needed. The manipulation feature may beon or off axis, inside or outside the canal wall, and penetrating ornon-penetrating with respect to the canal wall. One key aspect of themanipulation feature in the SES in some embodiments is to allow controlfor reversibility of the procedure.

Disclosed herein are various methods of removing the prosthetic devices,including SES 401, in cases where reversibility or repositioning isdesired. In some embodiments, a minimally invasive retrieval device canbe deployed via the containing a retrieval wire with a feature thatlinks with the manipulating feature 403 in the SES 401, as shown in FIG.4B. In some embodiments, the manipulating feature 403 can be linked viaa hook-loop, hook-hook, or loop-hook type set-up. In some embodiments,one or both of the retrieval or manipulating feature 403 can includecomplementary magnets, a gripper including, for example, movable jaws,an adhesive, a suction mechanism, and the like. In some embodiments, theretrieval device may wind-in the SES 401 into a track or threadedfeature within the devices. The insertion, anchoring/connection to 403and the removal of the SES 401 may all be performed by external controls(outside the body) of the devices in some cases.

Disclosed herein are embodiments of prosthetic devices such as SES 401in a wire form with a manipulating feature or features 403 at theproximal or distal end of the SES. FIG. 4B illustrates various views ofsuch an embodiment. The manipulating feature can be, for example, aneyelet 403 extending radially inwardly or outwardly in otherembodiments, or other features as disclosed elsewhere herein.

Disclosed herein are embodiments of prosthetic devices such as SES 401in a flat or angulated ribbon form with a manipulating feature orfeatures 403 at the proximal or distal end of the SES. For example, thestructure could be generically helical with a plurality of revolutionsas shown, with a flattened cross-section such as oval or rectangular forexample. FIGS. 5A-5C illustrate various views of an embodiment of theSES 401 where the tension rings 404 are continuous along the length ofthe SES 401, but in varying diameter. In other embodiments, either orboth of the central or lateral portions can have gradual or steppedvariable diameters. Manipulation features 403, such as eyelets or otherdisclosed herein, can be attached, connected, or integrally formed atone or both ends of the device, or at other locations, and be made ofthe same, or different materials as the rest of the device itself. Insome embodiments, the expanded length and/or number of rotations of thelarger diameter central portion is about, or no more than about 50%,60%, 70%, 80%, 90%, or more of that of the entire expanded length and/ornumber of rotations of the device.

Disclosed herein are methods for deploying prosthetic devices, such asadjustable reversible self-expanding eye stents (SESs) or eye tensionrings (ETRs) within the Schlemm's canal. In some embodiments, theleading edge or other portion of the SES 401 can be inserted using aninsertion device between the Schlemm's canal. In some embodiments, uponpartial or complete insertion, the SES 401 can spring into place,assuming a radially expanded configuration, and keep the Schlemm's canalwide-open, due to the shape-memory nature of the SES 401 material. Insome embodiments, multiple SESs 401 of similar or varying diameters canbe deployed within the depending on the Schlemm's canal anatomy. Someembodiments can include 2, 3, 4, 5, 6, 7, 8, 9, 10, or more devices, orranges including any two of the foregoing values, such as between 1 and10 devices, or between 2 and 8 devices for example. Each device can beplaced directly adjacent to, e.g., in contact with each other,overlapping with each other, or spaced apart and not directly contactingeach other, or combinations thereof. Additionally, some embodiments mayhave one, two, or more relatively larger diameter tension rings 404within the SES 401 relative to other rings of the SES that are eithercentrally located or positioned elsewhere depending on the anchoringrequirements within the Schlemm's canal. In other embodiments, multiplesuch SESs 401 may be deployed within the canal. In some embodiments, onelarge SES could be deployed covering the entire length or perimeter ofthe Schlemm's canal, with similar or varying diameter along its length,as shown in FIG. 5A or 5 B.

Disclosed herein are embodiments of prosthetic devices, including SES401 that can connect eye tension rings 404 via a connecting anchor orsupport structure 600 for stability, as shown in FIGS. 6A and 6B. Insome embodiments, there may be several of the eye tension rings 404connected in a similar continuous or separate manner.

Disclosed herein are embodiments of prosthetic devices, including SES401 that are non-continuous independent tension rings 404 with amanipulating feature 403 (that may be positioned outside or inside thecanal 400), as shown in FIGS. 7A and 7B. In some embodiments, these SESs401 may be inserted one at a time or several across various locationswithin the canal 400.

Disclosed herein are embodiments of prosthetic devices, including SES401 that are of variable pitch and length, as shown in FIGS. 8A and 8B.The SES 401 may have a by-pass and/or dilating feature 800 to regulateaqueous flow through the canal and/or by-pass of fluid within and acrossthe canal. This feature 800 may be at the entry of the canal wall asshown in FIG. 8C, which may also serve to anchor the SES 401 in thecanal along with ease of manipulation to reposition or retrieve the SES401 device within or away from the canal.

Disclosed herein are embodiments of prosthetic devices, including SES401 that are of variable pitch and length, as shown in FIGS. 9A-9D. TheSES 401 may have multiple by-pass and/or dilating features 800 and 900to regulate aqueous flow through the canal and/or by-pass of fluidwithin and across the canal. These features 800 or 900 may be at eachend of the SES device 401 or continuously along the length of the device401. These features as shown in FIGS. 9A-9D may also serve to anchor theSES 401 in the canal along with ease of manipulation to reposition orretrieve the SES 401 device within or away from the canal, as shown inFIG. 9E. Additionally, these features may have varying inner diameter901, similar to tube or channels to control entry and out-flow of fluidacross and within the canal. Additionally, the entry access or by-passfeatures 800 or 900 may be at several locations (2, 3, 4, 5, etc.) alongthe length of canal and may be fully enclosed within the canal, orpartially or fully across the canal into the anterior chamber.

Disclosed herein are embodiments of prosthetic devices, including SES401 that are of variable pitch across the free length of the SES 401, asshown in FIGS. 10A-10F. The variation of the pitch of the helical coilof the SES 401 may be utilized to regulate and customize dilation,by-pass, anchor, and manipulation of the SES 401 to regulate aqueousflow and IOP.

Disclosed herein are embodiments of prosthetic devices, including SES401 that are of variable pitch and diameter and shape across the freelength of the SES 401, as shown in FIGS. 11A-11J. The variation of thepitch and diameter of the helical coil along the free length of the SES401 may be utilized to regulate and customize dilation, by-pass, anchor,and manipulation of the SES 401 to regulate aqueous flow and IOP.

Disclosed herein are embodiments of prosthetic devices, including SES401 that have unique shapes, such as hooks or C-loops or rings oreyelets to control positioning, deployment, anchoring, removal,retrieval, and general manipulation of the SES 401. These features mayallow the SES 401 to regulate and customize dilation, by-pass, anchor,and manipulation of the SES 401 to regulate aqueous flow and IOP.

Disclosed herein are embodiments of prosthetic devices, including SES401 that have a polymeric sheath across the SES 401. Certain embodimentsas shown in FIGS. 13A and 13B may have the sheath across the coil of theSES 401 at the entry, exit, center, or various zones within the lengthof the SES 401, or continuously through the entire length of SES. Thissheath may allow regulation and customization of dilation, by-pass,anchor, and manipulation of the SES 401 to regulate aqueous flow andIOP. The polymeric sheath may be made of various degradable andnon-degradable polymers, including polytetrafluoroethylene (PTFE),silicone, lubricants, degradable polymers, hydrophobic polymers,hydrophilic polymers, hybrid polymers, etc. The polymeric sheath may becontinuous or discontinuous across the length and diameter of the SES401. The polymeric sheath may be cast, molded, spray-coated, dip-coated,or coated using other techniques over the base metal, alloy or polymericcoil that constitutes the SES 401.

Disclosed herein are embodiments of prosthetic devices, including SES401 that can form a double-helix or return pattern as shown in FIG. 14,in some cases with two discrete ends distally and a continuous loop endproximally without free ends. In some embodiments, there are twomanipulating features 403 shown with both in the entry plane on thedistal end of the device 401, although some embodiments could includeonly one, or three, four or more manipulating features for example.

Disclosed herein are embodiments of methods to use pre-operativemeasurements of the intraocular pressure (IOP) to customize the device,e.g., SES diameter, length, and pitch for the specific requirement ofIOP reduction. Yan et al (2016—Schlemm's Canal and Trabecular Meshworkin Eyes with Primary Open Angle Glaucoma: A Comparative Study UsingHigh-Frequency Ultrasound Biomicroscopy, PLOS One, 11 (1)https://doi.org/10.1371/journal.pone.0145824) have demonstrated thecorrelation of Schlemm's canal diameter to IOP. FIG. 15 shows an exampleto determine and customize the SES 401 design to fit the desired outflowand thus desired IOP decrease for the specific patient. The aqueousoutflow in the uveolymphatic canal can be directly correlated to theextent of dilation of this vessel. One or a plurality of customizeddevices can then be manufactured and then implanted, e.g., in a separateprocedure. However, the sizing procedure and implantation procedure canbe combined into a single procedure in other embodiments.

Disclosed herein are embodiments of prosthetic devices, including SES401 that are configured to be delivered in a minimally invasive form andretain the intended shape in-situ. In some embodiments, the SES may becircular in shape with multiple sweeps (rotations). In some variants,SES 401 may have 2 to 30 total sweeps (or rotations), whole or partialsweeps, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 20, 25, or 30sweeps, or ranges including any two of the foregoing values. In someembodiments the pitch (separate between each ring) can be between about0.0001″ and about 0.1″, such as about 0.0001″, 0.0005″, 0.001″, 0.002″,0.003″, 0.005″, 0.01″, 0.05″, 0.1″, or ranges including any two of theforegoing values Disclosed herein are embodiments that either partiallyor wholly cover the Schlemm's canal, such as for example, at leastabout, about, or no more than about 10%, 20%, 30%, 40%, 50%, 60%, 70%,80%, 90%, 100% of the axial length of the Schlemm's canal, or rangesincluding any two of the foregoing values The illustrations shown herealso demonstrate the manipulation features 901 that allow ease ofmanipulation, relocation, and retraction using a separate retrievingdevice. In some embodiments, the implanted SES will not extend axiallyinto any other uveal regions. In some embodiments, the implanted SESextends axially into one or more of the uveal or trabecular meshworkregions.

Disclosed herein are embodiments of prosthetic devices, including SES401 that are delivered in a minimally invasive form and retain theintended shape in-situ. In some embodiments, the SES may be circular inshape with multiple sweeps (rotations). In some variants, SES 401 mayhave 2 to 30 total sweeps (or rotations), whole or partial sweeps. Insome embodiments the pitch (separate between each ring) can be between0.0001″ to 0.1″. Disclosed herein are embodiments that either partiallyor wholly cover the Schlemm's canal. The illustrations shown here alsodemonstrate the manipulation features 403 that allow ease ofmanipulation, relocation, and retraction using a separate retrievingdevice. In some embodiments, the central portion of the SES may have thelargest diameter to allow better anchoring within the Schlemm's canaland prevent migration within the, with gradually decreasing diametersfrom the central portion to one or both ends.

In some embodiments, the larger diameter portions of the prostheticdevices can have an average or maximum diameter, for example, about orat least about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%,70%, 80%, 90%, 100%, or more relative to the average or maximum diameterof the smaller diameter portions, or ranges including any two of theforegoing values.

Disclosed herein are embodiments of methods to use pre-operativemeasurements of the uveolymphatic features such as diameter, length,tension, modulus, etc. to customize the SES 401 device to adequatelyprovide tension and thus patency across the channel or canal, which inturn provides the required IOP reduction. Finite-element analysis (FEA)and modeling may be used to determine the patient anatomical sizing ofthe SES device 401 including features such as coil diameter, overalltube/device diameter, pitch, variance in pitch, entry and exitdimensions, etc.

In some embodiments the SES device 401 may be directly implanted andslid into the uveolymphatic canal. FIG. 16A illustrates variants of theSES device made with shape-memory alloys and polymeric materials. FIGS.16B and 16C shows the SES device 401 in-situ in the uveolymphatic vessel400, adequately dilating the canal/vessel. Variants shown FIG. 16A maybe utilized depending on the required dilation of the canal/vessel.

In some embodiments the SES device 401 may be delivered into theuveolymphatic canal/Schlemm's canal from the angle in the anteriorchamber 1703, or outside the eye in the sub-conjunctival region, or thelimbus region 1702 or the scleral region 1704. FIG. 17 illustrates across-sectional view of the eye, with indications for various locationsof possible insertion of the SES device to access the uveolymphaticvessel/Schlemm's canal. One location shown is from the angle 1703 insidethe anterior chamber of the eye. Other locations outside the eye, suchas the limbus region 1702 or the sclera 1704 may be utilized to make anincision and access the uveolymphatic canal 400 directly below orunderneath the scleral tissue. The access may be made easier byselective staining or dying of the canal. Such an access may provideadditional benefits in safety and ease of delivery. Additionally, thecorneal region may also be used as a location for first incision.

Disclosed herein are embodiments of methods to advance, deliver,position, re-position, and/or retrieve the prosthetic devices, such asSES 401 in a minimally invasive form. Temperature of the SES 401 can bemanipulated (e.g., increased or decreased) by an insertion tool whosetemperature can be externally controlled through an energy source(electrical, mechanical, thermal, RF, ultrasonic, etc.), such that itcan alter the shape (shrink or expand) of the SES 401 to make insertionor retrieval procedures both minimally invasive, responsive, and easy tomanipulate/handle. In some embodiments, the device can be repositionedby at least initially torqueing (e.g., twisting) the device rather thanaxially pushing or pulling the device in a proximal or distal direction.

Disclosed in FIGS. 18A-18C are embodiments of methods to advance,deliver, position, re-position, and/or retrieve the prosthetic devices,such as SES 401 in a minimally invasive form. In some embodiments,delivery device 1800 may contain an outer cannula 1801 to access theuveolymphatic vessel 400. The outer cannula 1801 may be made of metals,alloys, ceramics, or polymeric materials to access the canal. In someembodiments the outer cannula 1801 may have sharp leading edges toprovide an incision to access the vessel 400. In some embodiments, theouter cannula 1801 may house an inner cannula 1802 or the SES device401. In some embodiments the inner cannula 1802 may house the SES deviceand the inner cannula may be made of metals, alloys, ceramics, orpolymeric materials. FIG. 18 illustrates a variant of an SES deliverydevice 1800 containing an outer cannula 1801 that houses an innercannula 1802 that in turn houses the SES device 401. Sliders 1803 and1804 to move the cannulas and the device are highlighted. The radius ofthe outer cannula 1801 and inner cannula 1802 may match that of the eyeand canal 400 to allow adequacy in turn and advancement.

Disclosed herein are embodiments of methods to advance, deliver,position, re-position, and/or retrieve the prosthetic devices, such asSES 401 in a minimally invasive form. In some embodiments, deliverydevice 2000 may contain an outer cannula 1801 to access theuveolymphatic vessel 400.

FIGS. 19A-19C illustrate a variant of an SES delivery device 2000in-situ accessing the uveolymphatic vessel 400 using the outer cannula1801 and delivering the SES device 401 using the inner cannula 1802. TheSES device delivering the SES device 401 from the inner cannula 1802 isalso shown.

Disclosed herein are embodiments of methods to advance, deliver,position, re-position, and/or retrieve the prosthetic devices, such asSES 401 in a minimally invasive form. In some embodiments, deliverydevice 2000 may contain an outer cannula 1801 to access theuveolymphatic vessel 400. FIG. 20 illustrates a variant of an SESdelivery device 2000 that utilizes a positive pressure system 2001 tocontrol the advancement, deployment, and retraction of the SES device401. In some embodiments, the delivery device 2000 may contain a plunger2002 to control (increase or decrease the pressure) in the sealedchamber 2001 to control the movement of the SES device 401 further alongthe cannulas 1802 and 1801 into the uveolymphatic vessel 400. In someembodiments the delivery device 2000 may contain a channel with reducingperimeter, such as a cone 2004 to compress the SES device 401 into asmaller diameter into the inner 1802 or outer 1801 cannula or both. Insome embodiments the delivery device 2000 may contain a sealed region2005 (metal, alloys, ceramic, polymeric, silicone, foam, etc.) toprovide a high-efficiency conversion of pressure differential from thechamber 2001 to linear movement of the SES device 401. In someembodiments the 2001 chamber may be liquid, gas, or air filled to createa pressure-controlled device. The device may be additionally powered byexternal energy sources. In some embodiments, the delivery system 2000may be a provided as a unit to mate with existing syringes or deliverydevices for ease of use.

Disclosed herein are embodiments of methods to advance, deliver,position, re-position, and/or retrieve the prosthetic devices, such asSES 401 in a minimally invasive form. In some embodiments, deliverydevice 2000 may contain an outer cannula 1801 to access theuveolymphatic vessel 400. FIG. 21 illustrates a variant of an SESdelivery device 2000 that utilizes a positive pressure system to controlthe advancement, deployment, and retraction of the SES device 401. Insome embodiments the delivery device 2000 may contain a sealed region2105 (metal, alloys, ceramic, polymeric, silicone, foam, etc.) toprovide a high-efficiency conversion of pressure differential from thechamber 2101 to linear movement of the SES device 401. In someembodiments the 2101 chamber may be liquid, gas, or air filled to createa pressure-controlled device. The device may be additionally powered byexternal energy sources. In some embodiments the 2000 device may have aplunger or slider 2102 to control the delivery.

Disclosed herein are embodiments of methods to advance, deliver,position, re-position, and/or retrieve the prosthetic devices, such asSES 401 in a minimally invasive form. In some embodiments the deliverydevice may utilize various contact boards 2201 (or plates orfeather-boards) that may contact the SES device 401 at a point, area orplane such that it can incrementally advance or retreat the device inany direction. In some embodiments, these contact boards 2201 may bemade of metal, alloys, ceramic, polymeric, silicone materials. FIGS. 22Aand 22B illustrate representative sketches of such as setup to controlmovement of the SES device 401.

Disclosed herein are embodiments of methods to advance, deliver,position, re-position, and/or retrieve the prosthetic devices, such asSES 401 in a minimally invasive form. In some embodiments, the SES 401device may have a leading guidewire 2301 that may lead the SES 401device into the canal 400. In some embodiments, the guidewire 2301 mayselectively attach to the SES device 401 with a mating portion 2302 byan external control through a trigger or movement. In some embodiments,the guidewire 2301 may stretch the SES device 401 into a smaller outerdiameter to allow easier movement within the inner or outer cannula ofthe delivery system within or into the canal 400. In some embodimentsthe guidewire 2301 may be used to detach from or attach-to the SESdevice 401 using the mating portion 2302 that may be externallycontrolled trigger movement. FIGS. 23 and 23B illustrate a variant of anSES delivery device 2300 that utilizes a lead guidewire that canselectively attach/detach 2302 to the SES device to control theadvancement, deployment, and retraction of the SES device 401.

Disclosed herein are variants of the SES device 401 in a wire form thatmay be developed in non-helical forms with partial or semi-circularsweeps. In some other embodiments the SES device 401 in the wire formmay have sweeps, turns either complete or partial to adequately stentthe longitudinal section of the canal 400. FIGS. 24A-24C containillustrations and examples of some such embodiments.

FIGS. 25A-25C illustrate a curved and electropolished SES device 401formed from a single-stranded, helical, nickel-titanium or other metalwire. The SES device 401 of FIG. 25A displays a variable pitch along thelength of the device and finished closed loop ends as illustrated inFIGS. 25B and 25C. In preferred embodiments, the radius of curvature forthe SES device 401 may be designed to closely or exactly match thecurvature of the uveolymphatic canal perimeter in the globe, so that noforces are applied which could deform the canal. In addition to having aconforming shape, it is preferred that the SES 401 be highly flexiblewith a very low bending stiffness so that no significant deformingforces will be transmitted to the canal even if there is a mismatchbetween the shape of the SES device and the shape of the canal andchannel. In some less preferred embodiments, however, the radius ofcurvature and stiffness properties of the SES device may also bedesigned to provide some tension or additional expansion to improve thedrainage through the collector channels.

In preferred embodiments, the SES device 401 will display a combinationof (1) a very high flexibility, (2) a sufficient column strength toallow self-insertion, and (3) a sufficient hoop strength or crushresistance to maintain patency of the canal or channel. Morespecifically, the SES device 401 will preferably have very low bendingstiffness along its length and so that it has minimal or no ability todeform the curvature of the Schlemm's Canal or the uveolymphatic canalperimeter. In such instances, the width, diameter, or cross-section ofthe coiled or otherwise bent wire in the main body 2504 will besufficient to open and/or support the walls of the uveolymphatic canalto promote drainage of uveolymphatic fluid through the collectorchannels 2603, as described below.

While the helical monofilament SES device 401 of the present inventionwill have a very low bending stiffness and high flexibility, they willpreferably also have sufficient column strength so that they may beinserted into and advanced through at least a portion of the Schlemm'scanal without the use of a supporting mechanism or other deploymentstructure during implantation.

Additionally, the helical turns or other bends of the SES device 401will typically be configured to open and/or support the walls of theSchlemm's Canal or the uveolymphatic canal perimeter after the SESdevice is implanted therein so that fluid may flow through the mainchannel of the Schlemm's Canal or the uveolymphatic canal into thesurrounding collector channels.

FIGS. 25B and 25C illustrate closer view of the proximal and distal end,respectively. In some embodiments, the proximal end 2501 and/or distalend 2502 of the SES may have tighter, often but not necessarily closed,pitch 2503 in comparison to the main body 2504 of the device to allowsmoother travel across the channel during delivery and additionally actas a by-pass into the aqueous chamber for improved circulation anddrainage of fluid. The main body of the SES device 401 may have widerpitch 2504 to balance the least amount of material required to keep theuveolymphatic channel dilated for aqueous patency. In some embodiments,the SES may be processed via polishing methods such as mechanical,chemical, electrochemical polishing methods to improve the finish of thesurface(s) as well as improve the biocompatibility of the surface(s). Insome embodiments, the ends of the SES may be welded or otherwise roundedusing LASER, heat, microwave, or other energy sources to form a closedloop 2505 or other desired shape for ease of travel and saferimplantation, as shown in FIG. 25C.

Disclosed herein are variants of the SES device in situ. FIG. 26Aillustrates a variant of a curved and electropolished SES device 401 insitu in the uveolymphatic canal 400. The narrow-gauge wire of the 401device prevents it from blocking the collector channels 2603 across theperimeter of the canal 400. In some embodiments, the SES device 401 mayhave even pitch across the length of the device. In some otherembodiments as shown in FIG. 26A the SES device 401 may have tightlywound pitch towards the two ends 2601 and 2604 and wider pitch towardsthe main body 2602. The wider pitch 2602 on the main body can provideadequate patency of fluid within the channel without blocking any of thecollector channels. The tightly wound ends can provide a complete orpartial by-pass of fluid from the anterior chamber into the channel foraid fluid flow, clearance and reduce intraocular pressure. In someembodiments (as shown in FIG. 26B) the SES device 401 may reside in situin the uveolymphatic canal 400 to dilate the canal with the proximal end2601 extended across the channel at the wound 2605 into the anteriorchamber to create by-pass for fluid flow. In similar embodiments, thewound 2605 and the proximal end 2601 can provide uninterrupted aqueousflow and clearance into the dilated uveolymphatic channel 400 to reduceintraocular pressure. In some embodiments, such a by-pass may beprovided at both ends of the device. In some embodiments, (as shown inFIG. 26C) the SES device 401 may reside in situ in the uveolymphaticcanal 400 to dilate the canal while with the proximal end 2601 extendsalong the same plane as the channel to create a partially collapsedwound opening 2605, i.e., the canal to the left of the wound opening inFIG. 26C is collapsed by the coil, and by-pass for fluid flow. In someembodiments, such a by-pass may be provided at both ends of the device.FIG. 26D contains a perspective closer view of the proximal end by-passvariant where the tightly wound proximal and/or distal end 2061 can beseen residing outside the canal 400 with access into the canal 400 atthe wound 2605. The wider main body of the narrow gauge wire 2602 isshown to not block the collector channels 2603.

As shown in FIG. 26C-1, in some instances, the coil at proximal end 2605of the SES 400 which is positioned through the wound 2605, as shown inFIG. 26C, may have an open pitch that permits both axial flow through anopen end of the coil in the direction of arrow A1 and lateral flow intothe coil through exposed openings between adjacent turns of the coil inthe direction of arrow A2. This is a particular advantage as it enhancesfluid flow into the canal 400 which has been opened by the SES 401.

Disclosed herein are variants to deploy the SES device. FIG. 27illustrates a variant of a slide-inserted device to deploy the SES and adetailed exploded view of such a delivery system. In some embodiments,the SES delivery system may use a sliding action delivery system. Insome embodiments, the delivery device may comprise of a body 2707, setscrews 2704, 2705 to control position of the outer or inner cannula2701. In some embodiments a plunger made of a wire or braided wire 2702may be used to deploy, delivery or retrieve the SES device. In someembodiments, the plunger 2702 may be controlled using a sliding wire2703 which may be controlled using a slider 2706 resting within theinserter body 2707.

Disclosed herein are embodiments of methods to deliver the prostheticdevice such as SES 401. In some embodiments, fluid pressure with asealed region may be used to deliver the device. In some otherembodiments, feather-boards or collet advancers may be used to deliverthe device, such that horizontal compression may lead to vertical motionor vice versa. In some other embodiments, shape-memory setting of theSES device 401 may be employed to deliver the device is a wire and haveit self-expanded in-situ in the canal 400. In some other embodiments,the delivery device may have an un-coiler channel to improve vector andreduce friction in delivery the SES device 401. In some otherembodiments, the SES device 401 may be pre-tightened or wound-up anddelivered in this state and may relax and uncoil or expand in-situ inthe canal 400. In some embodiments, torsional or axial rollers may beused to deliver the SES device 400 within the cannulas of the deliverydevice an in-situ in the canal 400. In some embodiments, piezo-electricvibrations with micromotors and vibrations may be used to deliver theSES device.

Disclosed herein are embodiments of methods to use pre-operativemeasurements of the Schlemm's canal physiology to customize the device,e.g., SES for the specific requirement. Imaging techniques such asoptical microscopy, ultrasonography, fluoroscopy, near infra-redimaging, CT-scan, measurement of CSA (cross-sectional area), diameter,can be utilized, such as in a pre-treatment procedure to determine andcustomize the SES 401 design to fit the specific physiological andanatomical need of the patient. One or a plurality of customized devicescan then be manufactured and then implanted, e.g., in a separateprocedure. However, the sizing procedure and implantation procedure canbe combined into a single procedure in other embodiments.

It is contemplated that various combinations or sub combinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment can be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the invention issusceptible to various modifications, and alternative forms, specificexamples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “inserting the SES proximate to the distal end of theSchlemm's canal” includes “instructing the inserting an SES proximate tothe distal end of the Schlemm's canal.” The ranges disclosed herein alsoencompass any and all overlap, sub-ranges, and combinations thereof.Language such as “up to,” “at least,” “greater than,” “less than,”“between,” and the like includes the number recited. Numbers preceded bya term such as “approximately”, “about”, and “substantially” as usedherein include the recited numbers, and also represent an amount closeto the stated amount that still performs a desired function or achievesa desired result. For example, the terms “approximately”, “about”, and“substantially” may refer to an amount that is within less than 10% of,within less than 5% of, within less than 1% of, within less than 0.1%of, and within less than 0.01% of the stated amount.

What is claimed is:
 1. A device for maintaining patency of a channel ofan uveolymphatic region or a Schlemm's canal in a patient's eye, saiddevice comprising: an expansion member consisting of a single elongatedelement having a bent configuration configured for radial expansion ofthe channel when inserted into the channel; wherein the expansion memberin its bent configuration has (i) sufficient radial strength towithstand compressive stresses exerted by the channel and (ii)sufficient void space in its structure to minimize blockage of theblocking of collector channels in the channel, when the expansion memberis implanted in the channel.
 2. The device for maintaining patency ofclaim 1, wherein the single elongated element comprises a pre-shapedmetal or polymeric filament.
 3. The device for maintaining patency ofclaim 2, wherein the single elongated element comprises a pre-shapedmetal wire.
 4. The device for maintaining patency of claim 3, whereinthe single elongated element comprises a shape or heat memory alloywire.
 5. The device for maintaining patency of claim 4, wherein thesingle elongated element comprises a nickel-titanium alloy wire.
 6. Thedevice for maintaining patency of claim 1, wherein the single elongatedelement in its bent configuration is at least partially formed withrepeating helical turns.
 7. The device for maintaining patency of claim1, wherein the single elongated element in its bent configuration is atleast partially formed with repeating serpentine loops.
 8. The devicefor maintaining patency of claim 1, wherein the single elongated elementis curved along its length in its bent configuration when free fromconstraint to conform to the shape of the channel.
 9. The device formaintaining patency of claim 1, wherein at least one end of the singleelongated element has a geometry different than that of the remainder ofthe single elongated element.
 10. The device for maintaining patency ofclaim 1, wherein both ends of the have a geometry different than that ofa central region of the single elongated element.
 11. The device formaintaining patency of claim 1, wherein the single elongated element isa shape memory alloy wire having a diameter in a range from 0.001 mm to1 mm and formed into a cylindrical helix having a central region with apitch between successive turns in a range from 0.001 mm to 10 mm anddiameter in a range from 0.001 mm to 10 mm when unconstrained.
 12. Thedevice for maintaining patency of claim 1, wherein at least one end ofthe single elongated element is formed into a helix having a tighterpitch and smaller diameter than those of the central region.
 13. Thedevice for maintaining patency of claim 12, wherein both ends of thesingle elongated element are formed into a helix having a tighter pitchand smaller diameter than those of the central region.
 14. The devicefor maintaining patency of claim 13, wherein tighter pitch is in a rangefrom 0.001 mm to 1 mm and the smaller diameter is in a range from 0.001mm to 1 mm.
 15. The device for maintaining patency of claim 1, whereinof the single elongated element has a radius of curvature selected tomatch that of the radius of curvature of the channel.
 16. The device formaintaining patency of claim 1, wherein the single elongated element hasbeen polished via mechanical, chemical or electrochemical methods toimprove finish and biocompatibility.
 17. The device for maintainingpatency of claim 1, wherein the single elongated element has at leastone end formed in a loop.
 18. The device for maintaining patency ofclaim 1, wherein the single elongated element has at least one endformed as a wound coil.
 19. The device for maintaining patency of claim18, wherein the coil at the at least one end is tightly wound.
 20. Thedevice for maintaining patency of claim 18, wherein the coil at the atleast one end has sufficient strength space between adjacent turns topermit fluid flow therethrough.
 21. The device for maintaining patencyof claim 1, wherein the single elongated element comprises at least onefeature at at least one end thereof configured to facilitatemanipulation.
 22. The device for maintaining patency of claim 1, whereinthe single elongated element is at least partially biodegradable orbioresorbable.
 23. The device for maintaining patency of claim 1,wherein the single elongated element comprises a drug-eluting memberformed on a surface thereof or embedded therein.
 24. The device formaintaining patency of claim 1, wherein the single elongated elementcomprises a hydrophilic or hydrophobic coating to aid in the safety andefficacy of the device within the eye.
 25. The device for maintainingpatency of claim 1, wherein the single elongated element includes aby-pass feature configured to permit aqueous flow between Schlemm'scanal and an anterior chamber of the eye.
 26. The device for maintainingpatency of claim 25, wherein the by-pass feature is located at an entry,an exit, or along a length of the device.
 27. The device for maintainingpatency of claim 1, wherein the single elongated element is formed atleast partly form a polymeric material selected from a group consistingof polyvinylidene fluoride, polyvinylidene difluoride (PVDF),polyvinylpyrrolidone (PVP), polyurethane, polyethylene glycol (PEG),polylactic acid (PLA), polycaprolactone (PCL), polyglycolic acid (PGA),polymethylmethacrylate (PMMA), polyacrylates, polyamide, polyimide,polyesters, silicone, and carbon-composites.
 28. The device formaintaining patency of claim 1, wherein the single elongated element isformed at least partly from a metal or metal alloy selected from a groupconsisting of titanium, stainless steel, cobalt-chrome alloy, gold,platinum, silver, iridium, tantalum, tungsten, aluminum, and vanadium.29. A method of treating glaucoma in a patient, comprising: implantingan expansion member consisting of a single elongated element in achannel of an uveolymphatic region or a Schlemm's canal of the patient;wherein the single elongated element opens the channel with (i)sufficient radial strength to withstand compressive stresses exerted bythe channel and (ii) sufficient void space in its structure to minimizeblockage of collector channels in the channel, when the expansion memberis implanted in the channel.